Quick answers
- What is Foscarnet sodium used for?
- The FDA-approved label (Foscavir, Clinigen Limited, December 11, 2025) says: “INDICATIONS CMV Retinitis FOSCAVIR is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). Combination therapy with FOSCAVIR and ganciclovir is indicated for patients who have relapsed after monotherapy with either drug. SAFETY AND EFFICACY OF FOSCAVIR HAVE NOT BEEN ESTABLISHED FOR TREATMENT OF OTHER CMV INFECTIONS (e.g., PNEUMONITIS, GASTROENTERITIS) …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Foscarnet sodium have a boxed warning?
- Yes. The FDA label for Foscavir has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Foscarnet sodium?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Foscarnet sodium been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Foscarnet sodium?
- 10 companies list prescription products of Foscarnet sodium in the FDA NDC Directory, including Clinigen Limited, Sagent Pharmaceuticals and Fresenius Kabi USA, LLC.
What Foscarnet sodium is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
INDICATIONS CMV Retinitis FOSCAVIR is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). Combination therapy with FOSCAVIR and ganciclovir is indicated for patients who have relapsed after monotherapy with either drug. SAFETY AND EFFICACY OF FOSCAVIR HAVE NOT BEEN ESTABLISHED FOR TREATMENT OF OTHER CMV INFECTIONS (e.g., PNEUMONITIS, GASTROENTERITIS) …
— FDA label: Foscavir, Clinigen Limited, effective December 11, 2025. Read the full label on DailyMed →
The FDA has 10 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
10 of 10 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Injection |
|---|---|
| Route | Intravenous |
| Prescription products | 10 in the FDA NDC Directory |
| Brand names | Foscavir |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Clinigen Limited2 products
- Sagent Pharmaceuticals1 product
- Fresenius Kabi USA, LLC1 product
- Amneal Pharmaceuticals LLC1 product
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1 product
- Caplin Steriles Limited1 product
- Somerset Therapeutics, LLC1 product
- Gland Pharma Limited1 product
- Baxter Healthcare Corporation1 product
- Hikma Pharmaceuticals USA Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020068 FOSCAVIR | Clinigen Hlthcare | September 27, 1991 | 20, latest October 28, 2020 2020: Manufacturing (CMC) · 2017: Labeling · 2016: Labeling |
Generic approvals (6)
- ANDA212483Fresenius Kabi USA · January 29, 2021
- ANDA213001Gland · April 21, 2021
- ANDA213807Avet Lifesciences · June 5, 2023
- ANDA213987Sciecure · November 29, 2023
- ANDA216602Amneal · March 1, 2024
- ANDA220068Caplin · May 13, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 855613, 1734377 |
|---|---|
| SPL set ID of the quoted label | 90e3da4e-3b1f-428b-99ca-e4bed1c80028 |
| FDA labels (SPL) | 10 |
| FDA applications | NDA020068, 6 ANDA |
| Active ingredients (FDA) | FOSCARNET |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Foscavir, Clinigen Limited, effective December 11, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →